跳至主要内容
临床试验/NCT04917211
NCT04917211招募中不适用

Use of a Virtual Reality Mask in the Reduction of Pain and Anxiety During in Utero Surgical Procedures

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
2
主要终点
the orimary outcome is the success of the virtual reality mask for analgesia defined by the absence of pain expressed by the woman (no administration of morphine (remifentanil)).

研究概览

简要总结

"The virtual reality mask is an innovative technique, alternative to pharmacological medicine that would allow, in addition to its action on pain, to reduce anxiety and thus increase patient satisfaction by improving their experience of a risky situation. The therapeutic effects of the virtual reality mask are based on a distractive effect with attentive capture, an emotional effect due to ludic aspect and positive suggestion, and a behavioral effect.

In utero fetoscopy is a potentially painful procedure, particularly at the beginning of the procedure due to the introduction of a fetoscopy trocar in the amniotic cavity through the patient's uterus. It also generates anxiety in mothers because of the risks associated with the pathology and the procedure. This research focuses on the use of a virtual reality mask in the reduction of pain and anxiety during in utero surgical procedures.

The study is presented and proposed to the patient during the expert ultrasound examination by the obstetrician-gynecologist. Then the modalities are detailed by the anesthetist during the anesthesia consultation before the surgery. The patient is included in the study after the consent is signed. During the anesthesia consultation, the patient is informed of the possibility of analgesia through a virtual reality mask, associated with local anesthesia. It is explained that in case of pain despite the virtual reality mask and local anesthesia, remifentanil administration remains possible. During the anesthesia consultation, the patient's initial state of anxiety is assessed by the score Amsterdam Preoperative Anxiety and Information Scale.

The procedure takes place in the theatre room. Upon arrival in the theatre room (preoperative), an evaluation of the anxiety level is performed using a visual analog scale. The virtual reality mask is applied by the anesthesia team before skin disinfection and the placement of sterile drapes. During the procedure, a local anesthesia (non-adrenaline Xylocaine 1%) is performed as usual in order to insert the trocar in the amniotic cavity (diameter 3.5mm) which will be used to introduce the intra-amniotic fetoscope. If during the procedure, the patient feels pain, agitation, pain-related discomfort, morphine analgesia (Intravenous Remifentanil which means Intravenous Anesthesia with Objective Concentration) may be administered by the anesthesia team. Immediately after the procedure, the virtual reality mask will be removed.

详细描述

"The use of the virtual reality mask associated with local anesthesia during in utero fetal surgery procedures by fetoscopy in the treatment of complications of monochorionic twin pregnancies, could be an alternative to the use of intravenous remifentanil associated with local anesthesia. It would allow analgesia and reduction of patient anxiety, thus simplifying the procedure for both patients and surgeons.

The virtual reality mask is an innovative technique, alternative to pharmacological medicine that would allow, in addition to its action on pain, to reduce anxiety and thus increase patient satisfaction by improving their experience of a risky situation. The therapeutic effects of the virtual reality mask are based on a distractive effect with attentive capture, an emotional effect due to ludic aspect and positive suggestion, and a behavioral effect. The virtual reality mask has almost never been studied in a pregnant population, particularly in the context of in utero procedures associated with risks of fetal loss that further increase anxiety.

In utero fetoscopy is a potentially painful procedure, particularly at the beginning of the procedure due to the introduction of a fetoscopy trocar in the amniotic cavity through the patient's uterus. It also generates anxiety in mothers because of the risks associated with the pathology and the procedure. This research focuses on the use of a virtual reality mask in the reduction of pain and anxiety during in utero surgical procedures.

This is a prospective cohort study including pregnant women who have a complicated monochorionic twin pregnancy with an indication for fetal surgery (laser photocoagulation fetoscopy or Selective Termination of Pregnancy). The objective is to evaluate the success rate of the virtual reality mask for analgesia during fetoscopy in case of monochorionic twin pregnancies complicated. The success of the virtual reality mask for analgesia is defined by the absence of pain expressed by the woman (no administration of morphine (remifentanil)). The primary outcome is the administration or not of remifentanil. The secondary objectives are to evaluate firstly the variation in maternal anxiety when using the virtual reality mask, secondly the pain during the intervention and thirdly the maternal satisfaction.

The study is presented and proposed to the patient during the expert ultrasound examination by the obstetrician-gynecologist. Then the modalities are detailed by the anesthetist during the anesthesia consultation before the surgery. The presentation of the study and the signature of the consent can be done within two weeks prior to the procedure. The patient is included in the study after the consent is signed. During the anesthesia consultation, the patient is informed of the possibility of analgesia through a virtual reality mask, associated with local anesthesia. It is explained that in case of pain despite the virtual reality mask and local anesthesia, remifentanil administration remains possible. During the anesthesia consultation, the patient's initial state of anxiety is assessed by the APAIS score (Amsterdam Preoperative Anxiety and Information Scale). This is a validated score for the evaluation of patients' anxiety prior to a procedure. A score higher than 10 out of 20 indicates a high level of anxiety and helps to identify the most anxious patients. This score will therefore allow to evaluate the initial anxiety state by identifying two groups of patients according to their initial anxiety level: high (score strictly greater than 10) and normal (score less than or equal to 10), but also the mean initial anxiety score.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged more than 18 years old
  • Complicated biamniotic monochorionic twin pregnancy
  • Indication for fetal surgery: Fetoscopy laser photocoagulation or Selective termination of pregnancy.
  • Patient Consent
  • Affiliation to a social security coverage

排除标准

  • No understanding of the French language
  • Visually impaired or hard of hearing
  • Participation in another intervention research
  • Patient under State medical aid
  • Psychiatric disorders (schizophrenia, schizophreniform disorders)
  • Major neurocognitive disorders (dementias)
  • Migraine helped a basic treatment
  • Epilepsy with treatment
  • Pacemaker carrier
  • With lesions on the scalp

结局指标

主要结局

the orimary outcome is the success of the virtual reality mask for analgesia defined by the absence of pain expressed by the woman (no administration of morphine (remifentanil)).

时间窗: 2 days after the end of intervention

"administration of remifentanil: no=success; yes=failure".

次要结局

  • The total dose of remifentanil in microgram (in relation to the total duration of the intervention) in case of administration of remifentanil(2 days after the end of intervention)
  • Maternal anxiety(Baseline and immediately after the intervention)
  • Side effects(2 days after the end of intervention)
  • The rate of patients with a chosen virtual reality theme(2 days after the end of intervention)
  • Overall maternal satisfaction(The satisfaction questionnaire is filled out on day 1 or at the latest on day 2 after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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